Translational Medicine and Biomarker Study Operations Manager
Location: Somerville, Massachusetts, 02143, United States
Finch is a clinical-stage company developing novel microbiome drugs to serve patients with serious unmet medical needs. Our machine learning-based platform mines molecular data collected from human interventional studies to identify the microbial communities driving positive patient outcomes in different disease areas. By developing drugs from microbial communities that have already demonstrated therapeutic effects in humans, we are pioneering a new approach to drug discovery and rapidly transforming the promise of the microbiome into a reality for patients.
Our lead therapeutic candidate, CP101, is initially targeting the prevention of recurrent C. difficile infection (CDI). CP101 recently met its primary endpoint in a large placebo-controlled trial in recurrent CDI, providing the first positive pivotal data for an oral microbiome drug. We also have programs targeting the treatment of chronic hepatitis B, children with autism and serious GI symptoms, as well as two programs partnered with Takeda Pharmaceuticals targeting inflammatory bowel disease.
We are seeking someone to lead our biomarker operations for clinical trials and serve as a key contributor to Translational Medicine (TM) and Clinical Team. TM is part of the Clinical Development organization and plays a pivotal role in bringing innovative medicines to patients in need.
The ideal candidate for this position will provide support for clinical biomarker assay outsourcing (PK, PD, Biomarkers, Exploratory), strategic vendor management, operational planning and support of clinical studies including sample management and monitoring.
This role embraces the principles of a translational medicine mindset, with a focus on operational excellence. The ideal candidate will have a passion to help transform current treatment paradigms while working in an innovative and fast-paced small biotech environment.
- Lead clinical assay and biomarker outsourcing for multiple biomarker modalities (e.g., qPCR, Immunoassay, LC-MS, Flow cytometry, etc.) including operational support for vendor lead activities, data transfers, data flows and ensure quality and timely deliverables.
- Serve as the Subject Matter Expert in operational aspects of outsourcing of clinical biomarkers in support of clinical studies. Independently identify, and resolve complex issues, sample management, Vendor quality or performance issues and engage technical SME, Translational Medicine Leader, clinical trial leaders and data management as needed.
- Support clinical studies and contribute to clinical teams including clinical study protocol, input to site feasibility and operations manuals, informed consent forms including genomics, sample collection tables, instruction manual, central lab protocol/manual and other biomarker study setups.
- Lead strategic global vendor management including vendor benchmarking, partnership with Business Sourcing, partnership with Line Functions (e.g. Research, CMC, TM, Clin. Ops, other) and negotiations with external service providers (ESP) to ensure strategic alignment.
- Lead root cause analysis and devise creative solutions. Collaborate with internal Research, Manufacturing, Clinical Development functions, clinical teams, sites, and ESPs to develop best practices and continuous improvement initiatives and innovations.
- Serve as Translational Medicine and Biomarker Study Coordinator in clinical studies and contribute to the biomarker planning and operational execution
- Participate in the development of biosample operations strategy and biomarker sample operations within multiple clinical programs in accordance with the requirements of quality, ethical and regulatory standards, including ICH/GCP/GDPR. Provide operational/logistics support for the clinical trial as it relates to TM and BMs in areas such as:
- Review study concept sheet, clinical study protocol, and SOM for BMs (PK, PD, BMs) related sections (operational/logistics input).
- Coordinate the biomarker costs and coordinate the input from various types of sampling and assessments provided by SMEs.
- Contribute to site feasibility (including COB).
- Prepare and/or review of optional Genetic ICF, review the PK, PD, Biomarkers related sections of main ICF and review site specific changes related to BM assessments.
- Prepare the sample collection table for biomarker samples (coordinating input from SMEs).
- Prepare the BM lab instruction manual for all biomarker samples (coordinating input from SMEs)
- Work with TML and clinical team to operationally setup the central lab for BM assessments (e.g. sample processing instructions, materials, kits, labelling, storage, disposition, documentation, etc.).
- Review of biomarker related sections of central lab protocol and manual.
- Review biomarker sections for the study eCRF.
- Coordinate sample logistics for all clinical biomarkers under TM responsibility.
- Support operational inquiries regarding sample logistics of TM biomarkers throughout study.
- Coordinate Biomarker Study Coordination for study close-out activities.
- BS/BA in life sciences with minimum 3 years, or MS in life sciences, or PharmD with experience in supporting translational medicine and biomarker activities during clinical trials.
- Good understanding of the biopharmaceutical environment and biomarker implementation process in early stage of drug development.
- Have general knowledge of biomarker discovery methodologies (molecular biology).
- Experience in supporting clinical trials and working as part of clinical study team.
- Working knowledge of clinical trial conduct and Good Clinical Practice (GCP).
- Ability to work in teams and function in a cross functional organization requiring communication and training among clinical and research colleges
More About Finch
Here at Finch, we strive to create the best work environment and experience for you through our formal benefits programs and fringe perks. Together, we hope that we’ll create a fun & supportive environment in and out of the workplace as we strive to create a new class of therapeutics together to help patients.
- Our formal benefits include medical, dental, and vision coverage through Blue Cross Blue Shield in addition to life insurance and long-term & short-term disability policies. We offer discretionary and flexible paid time off policies. Should you choose to start or grow your family while working at Finch, we aspire to lead our peers by offering several months of paid parental leave. We also offer a generous non-discretionary 401K contribution to help teammates save for life beyond Finch in the future and other savings and investment opportunities.
- We also try to keep the workplace an inspiring and motivating place to work with our fringe perks. Our facilities in Somerville, MA* include an in-office gym with a shower and towel service, fully stocked kitchen with free snacks, iced coffee & flavored/sparkling waters on tap, and highly subsidized meals through LeanBox. We sponsor ride-sharing to and from the office from preset locations around Boston, Cambridge, and Somerville. We are always evaluating our fringe perks and hope to grow them alongside our team.
*Though only facility-dependent employees are currently working onsite in Somerville, Ma, we all plan to return to the office when it’s safe to do so.
Equal Opportunity Employer
We are committed to recruiting, developing, and retaining the most talented people from a diverse candidate pool. All aspects of employment including the decision to hire or promote, will be based on aptitude, performance, and business need. We do not discriminate on the basis of race, color, religion, sex, national origin, age, physical or mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, or any other legally protected status. Finch will make reasonable accommodations for qualified individuals with disabilities, in accordance with applicable law.